US11033290B2 - Medical device and methods of use - Google Patents

Abstract

The present disclosure is directed to a tissue removal device. The tissue removal device may include a distal portion. The distal portion may include an outer distal portion including a tissue removal tool, and an inner distal portion positioned within the outer distal portion and having a closed distal end, a lumen, and at least one side port, wherein the lumen is configured to receive a medical device, and the inner distal portion is movable relative to the outer distal portion and the medical device.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefits of priority from U.S. Provisional Application No. 62/270,249, filed on Dec. 21, 2015, the entirety of which is incorporated herein by reference.

TECHNICAL FIELD

The present disclosure relates generally to medical devices. More particularly, the disclosure relates to medical devices used, for example, for dissecting tissue. More particularly, embodiments of the disclosure relate to minimally invasive devices and methods for endoscopic mucosal resection, endoscopic submucosal dissection, and per-oral endoscopic myotomy (POEM). The disclosure also relates to methods of using such devices.

BACKGROUND OF THE DISCLOSURE

Colorectal Cancer is the second leading cause of death in the U.S. There is an unmet need for endoscopic tissue dissection of malignant and pre-malignant lesions. Current treatment options include endoscopic mucosal resection or surgery. Endoscopic resection, done in an outpatient setting, has the potential to dramatically reduce hospital stay as well as morbidity and mortality associated with surgical resection.

When attempting mucosal resection within the GI tract, especially the large intestine, lifting and separating the lesion from the muscularis layer is very challenging. Further, dissecting the ideal amount or layers of tissue may be challenging.

SUMMARY OF THE DISCLOSURE

Aspects of the present disclosure relate to medical devices used for dissecting tissue.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive.

In one example, a tissue removal device may include a distal portion. The distal portion may include an outer distal portion including a tissue removal tool, and an inner distal portion positioned within the outer distal portion and having a closed distal end, a lumen, and at least one side port, wherein the lumen is configured to receive a medical device, and the inner distal portion is movable relative to the outer distal portion and the medical device.

Examples of the medical device may additionally and/or alternatively include one or more other features. Features of the various examples described in the following may be combined unless explicitly stated to the contrary. For example, the at least one side port is configured to apply suction to tissue adjacent to the inner distal portion. The tissue removal device may include the medical device, wherein the distal portion attaches to the medical device. The medical device may be in fluid communication with the lumen of the inner distal portion and the at least one side port. The distal portion may be removably attached to the medical device. The at least one port may include a plurality of ports disposed on between approximately 270 degrees and approximately 90 degrees of a circumference of the inner distal portion. The tissue removal tool may be disposed on between approximately 200 degrees and approximately 90 degrees of a circumference of the outer distal portion. The inner distal portion and the outer distal portion may be positioned so that the tissue removal tool circumferentially aligns with the plurality of ports. The tissue removal device may include a gap between an outer surface of the inner distal portion and the inner surface of the outer distal portion, wherein the radial width of the gap may be between approximately 3 mm and approximately 8 mm. The medical device may be an endoscope. Each of the inner distal portion and the outer distal portion may have a first axial position relative to the medical device and a second axial position relative to the medical device. When in the second axial position, the inner distal portion may be configured to apply suction to a target tissue. The outer distal portion may be configured to dissect the target tissue when the outer distal portion transitions from the first position to the second position. The outer distal portion may be configured to dissect the target tissue when the inner distal portion transitions from the second position to the first position. A distal end of the inner distal portion may be clear.

In another example, a method of dissecting tissue may include inserting a delivery device with a distal portion into a patient, wherein the distal portion includes an inner distal portion and an outer distal portion, the distal portion is external to the delivery device during insertion, and each of the inner distal portion and the outer distal portion is in a first position during insertion, positioning the distal portion proximal to a target tissue, extending the inner distal portion to a second position adjacent the target tissue, applying suction through the delivery device to at least one port disposed in the inner distal portion, and securing the target tissue to the inner distal portion.

Examples of the method of operating the medical device may additionally and/or alternatively include one or more other features. For example, the method may include extending the outer distal portion to a second position, and dissecting the target tissue with a tissue removal tool of the outer distal portion, when the outer distal portion transitions from the first position to the second position. The method may include after securing the target tissue to the inner distal portion, retracting the inner distal portion to the first position, and dissecting the target tissue with a tissue removal tool of the outer distal portion, when the inner distal portion transitions from the second position to the first position. The method may include after securing the target tissue to the inner distal portion, initiating a cautery wire or extending a cutting blade. The distal portion may be removably attached to the medical device. The medical device may be an endoscope.

In another example, a tissue removal device may include a delivery device having an inner lumen extending from a proximal end of the delivery device to a distal end of the delivery device, a distal portion attached an outer surface of to the delivery device. The distal portion may include an outer distal portion including a tissue removal tool, wherein the outer distal portion may be axially movable relative to the delivery device; and an inner distal portion with a closed distal end and at least one side port in fluid communication with the lumen of the delivery device, wherein the inner distal portion may be axially movable relative to the delivery device and the outer distal portion.

Examples of the medical device may additionally and/or alternatively include one or more other features. Features of the various examples described in the following may be combined unless explicitly stated to the contrary. For example, the tissue removal tool may be one of a cautery wire or a cutting blade. When the inner distal portion is in a first position, a proximal-facing wall of the inner distal portion may contacts the distalmost end of the outer distal portion.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various examples and together with the description, serve to explain the principles of the disclosure.

FIGS. 1A and B illustrate a side view and a perspective view of an exemplary delivery device and an exemplary distal portion including an inner distal portion in a first position and an outer distal portion in a first position;

FIG. 2 illustrates a proximal facing view of an exemplary distal end of the medical device ofFIGS. 1A and B;

FIGS. 3A and 3B illustrate a side view and a perspective view of the medical device ofFIGS. 1A and B in which the inner distal portion is in a second position and the outer distal portion is in the first position;

FIG. 4 illustrates a side view of the medical device when suction is applied to target tissue through the inner distal portion in the second position and with the outer distal portion in the first position;

FIG. 5 illustrates a proximal-facing view of an exemplary distal end of an exemplary inner distal portion with target tissue pulled by suction around the inner distal portion;

FIG. 6 illustrates a side view of an exemplary delivery device and an exemplary distal portion including an inner distal portion in a second position and an outer distal portion in a second position;

FIG. 7 illustrates a side view of an exemplary delivery device and an exemplary distal portion after dissection with the inner distal portion in the first position and the outer distal portion in the first position;

FIG. 8 illustrates an exemplary distal portion with an exemplary dissection tool;

FIG. 9 illustrates an exemplary distal portion with an alternative exemplary dissection tool; and

FIG. 10 illustrates a side view of an alternative exemplary distal portion.

DETAILED DESCRIPTION

Reference is now made in detail to examples of the present disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. The term “distal” refers to a position farther away from a user end of the device. The term “proximal” refers a position closer to the user end of the device. As used herein, the terms “approximately” and “substantially” indicate a range of values within +/−5% of a stated value.

Aspects of the present disclosure relate to systems and methods for dissecting tissue. The medical devices described herein include a distal portion which is attached to delivery device and may be coaxial with the delivery device. The distal portion includes an inner distal portion and an outer distal portion delivering a radial gap therebetween. The inner distal portion allows for suction to secure tissue to be resected (e.g., target tissue) and the gap between the inner distal portion and the outer distal portion provides a fixed depth resection to reduce the risk of perforation. Additionally, the distal portion may be used with or without injection to lift the tissue, for example a lesion.

It should be noted that the target tissue may be at any location in the body. In some examples, the target tissue may be anywhere within the gastrointestinal (GI) tract including, but not limited to, the large intestine.

FIGS. 1A and 1B illustrate a distal end of an exemplary medical device for dissecting tissue. The device may include adelivery device102 and adistal portion142.Distal portion142 may include an innerdistal portion132, an outerdistal portion162, adock110, and anattachment section118.Delivery device102 may either be integral withdistal portion142 or may be coupled to a separate and distinctdistal portion142.

Delivery device102 may be any device known in the art capable of providing suction to a distal end (e.g., an endoscope, sheath, catheter, ureteroscope, etc.).Delivery device102 may be used for procedures within or adjacent to various body organs, such as, an esophagus, a heart, a stomach, a pelvic area, a bladder, an intestine, or any other portion of a gastrointestinal, urinary, or pulmonary tract.Delivery device102 may be configured for insertion into a patient's body through an anatomical opening. In some embodiments,delivery device102 may be used in natural orifice transluminal endoscopic surgery (NOTES) procedures or single incision laparoscopic surgical (SILS) procedures. Accordingly,delivery device102 may be shaped and sized for placement into a patient via a body cavity or an incision.

Delivery device102 includes a proximal end (not shown) and adistal end104. The proximal end ofdelivery device102 may be coupled to a handle portion (not shown). The handle portion and/or the proximal end ofdelivery device102 may be attached to a vacuum source, an illumination source, an electrical source, and/or an imaging apparatus.

Delivery device102 may include one or more working channel(s) (e.g., workingchannel114 as shown inFIG. 1) extending substantially longitudinally (axially) between the proximal end and thedistal end104 ofdelivery device102. In some examples, workingchannel114 may be in fluid communication with a vacuum source (e.g., house vacuum, vacuum pump, etc.) to apply suction through workingchannel114 todistal end104 ofdelivery device102. The one or more working channels may have any suitable size, cross-sectional area, shape, and/or configuration to, for example, introduce medical instruments (e.g., resection tools) todistal end104 ofdelivery device102 and/or apply suction throughdistal end104 ofdelivery device102. In some examples, as shown inFIGS. 1B and 2,delivery device102 may include an imaging/illumination device112.

As previously mentioned,distal portion142 may includeattachment section118.FIGS. 1A and 1B illustratedistal portion142 attached todelivery device102 viaattachment section118. There may be a fluid tight seal betweenattachment section118 anddelivery device102. In some examples,distal portion142 may be temporarily or permanently attached todelivery device102. By configuringdistal portion142 to complementarily engage with the distal end of a conventional delivery device (e.g., an endoscope or a catheter), the disclosed device can be used with any existing endoscopes and catheters. A permanently attached distal portion ensures thatdistal portion142 does not inadvertently separate fromdelivery device102 during a procedure. On the other hand, however, a removably coupled distal portion may allow for utilizing inner and outer distal portions of differing sizes to resect tissue of differing sizes and thicknesses. Based on the desired application, distal portions may be manufactured either permanently attached todelivery device102 or with attachment means to temporarily attach thedistal portion142 todelivery device102 having complementary attachment means.

For temporary attachment, the proximal portion ofdistal portion142 may include a substantiallyopen attachment section118, e.g., cylindrical opening for receivingdistal end104 ofdelivery device102. In some examples the exterior ofattachment section118 may taper. The taper may be curved (FIG. 1A) or substantially straight (FIG. 1B). The interior ofattachment section118 may include threading, projections, grooves, or any other temporary attachment means for attachingdistal portion142 to complementary structures on the elongate member. Thus, temporary attachments may, for instance, be defined by a screw-fit, Luer taper, snap-fit, or compression fit arrangement. In some embodiments,attachment section118 may be adjustable, allowing operators to connect elongate members of varying configurations or sizes todistal portion142. For instance,attachment section118 may be formed of a flexible material, such as elastic or rubber, which may expand radially to allowdistal portion142 to fit over a range of delivery devices with diameters greater than a diameter ofattachment section118 whenattachment section118 is in a normal state. It will be understood thatattachment section118 can be made from different materials and be configured differently to provide for adjustability without departing from the scope of the present disclosure. Furthermore, mechanisms for holdingattachment section118 todelivery device102 may be used, including, e.g., hose clamps, wrapped filaments, clips, etc.

Permanent attachment may include welding, gluing, soldering, or other forms of attachment, ordistal portion142 may be integrally formed withdelivery device102. It will be appreciated that other forms of temporary or permanent attachment may be adopted without departing from the scope of the present disclosure. In some embodiments,distal portion142 may be integral with a sheath which fits along a portion ofdelivery device102 from the distal end and proximally. In further examples, this sheath may extend substantially the entire length ofdelivery device102.

As previously mentioned,distal portion142 may include innerdistal portion132, outerdistal portion162,dock110, andattachment section118. Dock110 may connect innerdistal portion132, outerdistal portion162, andattachment section118. In some examples,dock110 may contact and/or extend radially outward from an exterior surface ofdelivery device102. In some examples, as described in further detail below, dock110 houses the actuation mechanisms for innerdistal portion132 and outerdistal portion162.FIGS. 1A and 1B illustrate both innerdistal portion132 and outerdistal portion162 in a first position relative todelivery device102. As shown, in the first position, innerproximal control136 of innerdistal portion132 may contact a distal-facing wall ofdock110 and a proximal portion (e.g., outerproximal control137 ofFIG. 6) may contact a radially outward facing wall ofdock110.

Innerdistal portion132 and outerdistal portion162 may be generally tubular members configured to be secured to and arounddistal end104 ofdelivery device102. Innerdistal portion132 may include a closeddistal end134. Outerdistal portion162 may include an open distal end. At least a portion of the distal end of outerdistal portion162 may include adissection tool164.Dissection tool164 will be described in further detail with respect toFIGS. 8 and 9. The proximal ends of innerdistal portion132 and outerdistal portion162 may be releasably connected to dock110. A proximal end ofdock110 may be coupled toattachment section118.

Distal portion142 may be made from any suitable biocompatible material known to one of ordinary skill in the art and having sufficient flexibility to traverse tortuous anatomy. Such materials may include, but are not limited to, rubber, silicon, synthetic plastic, stainless steel, metal-polymer composites, and metal alloys of nickel, titanium, copper cobalt, vanadium, chromium, and iron. In some examples, the material forming portions or all ofdistal portion142 may be a superelastic material such as nitinol, which is a nickel-titanium alloy. In some examples, some or all ofdistal portion142 may be transparent or translucent. In particular,distal end134 of inner distal portion132 (or all of inner distal portion132) may be transparent (e.g., made of a clear polycarbonate) to provide a clear view for an imaging and/or an illumination device (e.g., imaging/illumination device112 ofFIG. 1B.)

Portions or all ofdistal portion142 may be circular, ovoidal, irregular, and/or any shape suitable to enter a body. Further, outerdistal portion162 may have the same shape or a different shape than innerdistal portion132. For example, both may have a substantially circular cross-section and be substantially cylindrical. Portions or all ofdistal portion142 may have a uniform shape from proximal end to distal end. In some examples, portions or all ofdistal portion142 may have a varying shape, such as a taper at the distal end to facilitate insertion within the body.

Innerdistal portion132 may include a closeddistal end134, a hollow, cylindrical bore, and/or a plurality ofside ports122. The bore of innerdistal portion132 may be in fluid communication with the plurality ofside ports122 and with workingchannel114 ofdelivery device102. As such, when suction is applied through workingchannel114 todistal end104 ofdelivery device102, suction is similarly applied throughside ports122. In some examples,ports122 may be substantially or at least partially facing radially outward (e.g., the axis of eachport122 may be approximately perpendicular to the longitudinal axis of inner distal portion132) orports122 may be angled towarddistal end134 of innerdistal portion132 so suction is applied toward the distal end of the medical device. The angling of suction applied throughports122 may also include angling the passage(s) (e.g., branches extending from the interior of innerdistal portion132 to exterior of inner distal portion132) connected toports122. The angle ofports122 may be greater than approximately 10 degrees from the longitudinal axis of innerdistal portion132 to less than approximately 90 degrees from the longitudinal axis of innerdistal portion132, preferably between approximately 20 degrees and approximately 80 degrees. Angling the application of suction toward thedistal end134 of innerdistal portion132 may assist in securing target tissue located distally of innerdistal portion132.

There may be any number ofside ports122, spaced any distance apart, and located anywhere along the radial surface of innerdistal portion132. The plurality of ports may include any numbers of rows or columns. In some examples, innerdistal portion132 includes linear, evenly dispersed rows ofside ports122 extending circumferentially about innerdistal portion132, e.g., six evenly spaced rows as illustrated inFIG. 1B. In the examples illustrated herein, the rows are substantially linear, but the plurality of ports are not limited thereto and may be in any pattern. In some examples, each row includes any number of ports. In some examples, each row may include the same number of ports or each row may include a different number of ports than other row(s). For example,FIG. 1B shows four longitudinally arranged columns. In some examples, the density ofports122 may vary, e.g., ports may be closer together at the distal end than the proximal end or vice versa.

Ports122 may be disposed on any portion of the circumference of innerdistal portion132. For example, the ports may be located on an entire 360 degrees of the circumference of innerdistal portion132. In other examples, like those illustrated herein,ports122 may be disposed on between approximately 270 degrees and approximately 90 degrees, or approximately 180 degrees and approximately 120 degrees of the circumference of innerdistal portion132. In some examples,ports122 may be disposed on less than approximately 180 degrees.Ports122 may only be on a portion (e.g., less than 360 degrees) of the outer surface, so thatports122 may be positioned at or near target tissue and only pull target tissue toward innerdistal portion132.

Theside ports122 may be any size and/or shape. The size and/or shape ofports122 may depend on the size and/or type of target tissue. For example, the ports should be large enough to suction at least some of the target tissue into the port to provide traction. Conversely, theports122 should not be too large (and the suction force should not be so strong) as to suction in so much tissue as to inadvertently dissect deeper layers of tissue.Ports122 may be substantially circular and may have a diameter of approximately 2-4 millimeters. In some examples, each of the plurality ofports122 may have substantially the same diameter. In some examples, the diameter of each ofport122 may vary.

Distal portion142 may have any length, cross-sectional shape and/or configuration and may be any desired dimension that can be received in a body cavity, connect todelivery device102, and dissect the target tissue. For example, both innerdistal portion132 and outerdistal portion162 may have the same or different length. The length of innerdistal portion132 and outerdistal portion162 may be between approximately 15 mm and approximately 30 mm, or between approximately 20 mm and approximately 25 mm. In some examples, the inner diameter of innerdistal portion132 may be sized to surround and slide overdelivery device102. The gap between the innerdistal portion132 anddelivery device102 may be any size capable of allowing innerdistal portion132 to slide relative todelivery device102 in the longitudinal direction. In some examples, the outer diameter of innerdistal portion132 may be approximately 10 mm to approximately 15 mm, or approximately 12.5 mm. The inner diameter of outerdistal portion162 may be sized to surround and slide over innerdistal portion132. As illustratedFIG. 1A, there may be agap150 between a portion of inner distal portion132 (e.g., the portion with side ports122) and the outerdistal portion162. Anothersized gap151 may be between another portion of inner distal portion132 (e.g., a portion without side ports122) and the outerdistal portion162. In some examples, the gap between innerdistal portion132 and outerdistal portion162 may be substantially constant (e.g.,gap150 andgap151 are substantially the same forming an annular gap between innerdistal portion132 and outer distal portion162). In other examples,gap151 is smaller than gap150 (e.g., becausegap150 is configured to receive dissected tissue andgap151 is not). For example, an off-axis inner distal portion132 (e.g., the axis of innerdistal portion132 is not coincident with the axis of outer distal portion162) may maximizegap150 and thus achieve a maximum dissected/resected tissue thickness. In some examples, the circumference ofdistal portion142 associated withgap150 andgap151 may be defined bydissection tool164. For example,gap150 may be between innerdistal portion132 and a circumferential portion of outer distal portion162 (e.g., the portion with dissection tool164) andgap151 may be between innerdistal portion132 and another circumferential portion of outer distal portion162 (e.g., the portion without dissection tool164).Gap150 may have any radial width (e.g., the space between the outer surface of innerdistal portion132 and the inner surface of outer distal portion162). For example,gap150 may be between approximately 2 mm and approximately 9 mm in radial width, or between approximately 3 mm and approximately 8 mm, or approximately 5 mm. The radial width ofgap150 may depend on the target tissue. For example, the target tissue (e.g., the tissue desired for dissection) in the esophagus may be thicker than target tissue within the colon or duodenum. For a distal portion (e.g., distal portion142) designed for dissection within the esophagus,gap150 may be between approximately 6 mm and approximately 10 mm, or approximately 8 mm. In examples in whichdistal portion142 is designed for dissection within the colon or duodenum,gap150 may be between approximately 2 mm and approximately 4 mm, or approximately 3 mm.

FIG. 2 illustrates a proximal-facing view of the distal end of the medical device. As shown,delivery device102, including workingchannel114 and imaging/illumination device112, is disposed with innerdistal portion132.Gap150 separates innerdistal portion132 and outerdistal portion162. A portion (e.g., a cutting arc length) of the circumference of outerdistal portion162 includesdissection tool164. For example, thedissection tool164 may extend an entire 360 degrees of the circumference of outerdistal portion162. In other examples, like those illustrated herein,dissection tool164 may be disposed on between approximately 200 degrees and approximately 90 degrees, or approximately 180 degrees and approximately 120 degrees of the circumference of outerdistal portion162. In some examples,dissection tool164 may be disposed on approximately 180 degrees (as shown inFIG. 2). Exemplary dissection tools and their configuration within outerdistal portion162 are described in further detail below with respect toFIGS. 8 and 9.

Distal portion142 may enter a patient with both innerdistal portion132 and outerdistal portion162 in the first position relative todelivery device102.Distal portion142 may be placed just proximal of the target tissue and/or distal portion142 (or only inner distal portion132) may be rotated so thatside ports122 face the target tissue. Once in this orientation, innerdistal portion132 may be moved distally, to a second position so thatside ports122 are adjacent to the target tissue.FIGS. 3A and 3B illustrate a side view and a perspective view of the medical device with innerdistal portion132 in a second position relative todelivery device102 and outerdistal portion162 in a first position relative todelivery device102. The proximalmost end of innerdistal portion132 may not move beyond a distalmost end ofdelivery device102. Innerdistal portion132 and deliverdevice102 may form a fluid tight seal (e.g., between innerproximal control136 and an outer surface of delivery device102). Innerdistal portion132 may be moved in any way known in the art. In some examples, a pull/push mechanism may be used. Such mechanisms may be one or more pull wires, and/or single or multiple rod. In some examples, the actuation mechanism, may be actuationmechanism138.Actuation mechanism138 is disposed external todelivery device102. In the example shown inFIG. 3A,actuation mechanism138 extends betweendock110 and innerproximal control136. In some examples, an actuation mechanism may be disposed withindelivery device102. The actuation mechanism may extend through a working channel ofdelivery device102, e.g., workingchannel114.

FIG. 4 illustrates a side view ofdistal portion142 applying suction to targettissue130. In this example,distal portion142 may have first been positioned proximal oftarget tissue130. Innerdistal portion132 was moved so thatside ports122 aligned withtarget tissue130. Once in such a position, an operator may initiate a vacuum source to apply suction through e.g., workingchannel114 ofdelivery102. This suction may then be applied to targettissue130 throughside ports122 of innerdistal portion132. The rate of suction may depend on the size and/or type of target tissue. For example, the suction may be of sufficient force to pull at least some of the target tissue into the port to provide traction. Conversely, the suction should not be too large as to pull in so much tissue as to inadvertently dissect deeper layers of tissue. In some examples, the rate of suction may be between approximately 575 millibar to approximately 850 millibar.

FIG. 5 illustrates a proximal-facing view ofdistal end134 of innerdistal portion132 withtarget tissue130 pull around a circumferential portion of innerdistal portion132 via suction. Layer131 illustrates a deeper tissue layer thantarget tissue130. An operator may wish to avoid dissecting deeper layer131. By setting outer distal portion162 (and thus dissection tool164) a certain distance (e.g., the radial width of gap150) away from innerdistal portion132, the cross-sectional width of the dissected tissue may be limited to the radial width ofgap150, as illustrated by the dotted line ofFIG. 5. An operator may choose adistal portion142 and/orgap150 to ensure that the radial width ofgap150 does not exceed the cross-sectional width of the layer of tissue desired for dissected and thus, may avoid dissection deeper layers.

FIGS. 6 and 7 illustrate exemplary alternative methods ofdissecting target tissue130 withdistal portion142. In the example illustrated inFIG. 6, both innerdistal portion132 and outerdistal portion162 are in the second position relative todelivery device102. Once securing target tissue130 (e.g., as shown inFIG. 4) to innerdistal portion132, outerdistal portion162 may be moved distally. Outerdistal portion162 may be moved in any way known in the art. In some examples, a pull/push mechanism may be used. Such a mechanism may be one or more pull wires, and/or single or multiple rod. In some examples, the actuation mechanism may be actuationmechanism139.Actuation mechanism139 is disposed external todelivery device102. In the example shown inFIG. 6,actuation mechanism139 extends between outer proximal control137 (affixed to a radially outward facing wall of dock110) and a proximalmost end of outerdistal portion162. In some examples, an actuation mechanism may be disposed withindelivery device102. The actuation mechanism may extend through a working channel ofdelivery device102, e.g., workingchannel114.Dissection tool164 may slice thetarget tissue130 as outerdistal portion162 moves distally through the target tissue.Dissection tool164 may be used to dissect and collect a portion oftissue130 intogap150.

In the example illustrated inFIG. 7, both innerdistal portion132 and outerdistal portion162 are in the first position relative todelivery device102. Once securing target tissue130 (e.g., as shown inFIG. 4) to innerdistal portion132, innerdistal portion132 may be moved proximally, pulling portions of the target tissue proximally as well. In some examples, a higher amount of suction may need to be applied when using such a method. Innerdistal portion132 may be moved in any way known in the art, including those described above.Dissection tool164 may slice thetarget tissue130 as innerdistal portion132 moves proximally and pullstarget tissue130 throughdissection tool164.Dissection tool164 may be used to dissect a portion of130 tissue and collect the dissected tissue ingap150. In examples in which this method is used,distal portion142 may be designed so that outerdistal portion162 is fixed relative todelivery device102 and unable to move distally as shown inFIG. 6. In some examples, outerdistal portion162 is capable of moving distally as shown inFIG. 6, and, as appropriate, an operator may choose between the method illustrated inFIG. 6, the method illustrated inFIG. 7, and a combination thereof. When dissecting, at least a portion ofports122 of innerdistal portion132 are aligned with the cutting arc (e.g., the portion of outerdistal portion162 including dissection tool164). In some examples, all of the plurality ofports122 are within the cutting arc.

FIGS. 8 and 9 illustrate two exemplary dissection tools embedded with a portion of the circumference of outerdistal portion162.FIG. 8 illustrates acautery wire164 embedded within outerdistal portion162. Thewire164 may remain off or “cold” during insertion and positioning of innerdistal portion132 and outerdistal portion162. Once ready for dissection, the operator may initiate electricity to travel through a wire (e.g.,wire124 ofFIG. 1) from the proximal end of the delivery device to thecautery wire164. As innerdistal portion132 movestarget tissue130 towardwire164 and/or outerdistal portion162 moveswire164 towardtarget tissue130, the “hot”cautery wire164 may cut throughtarget tissue130 atcut line133.

FIG. 9 illustrates aretractable cutting blade166 embedded within outerdistal portion162. In some examples, thecutting blade166 may have a curved of semi-circular shape so as to be disposed along the entire cutting arc length of the circumference of outerdistal portion162. Thecutting blade166 may remain retracted during insertion and positioning ofdistal portion142. Once ready for dissection, the operator may push theretractable blade166 out of its housing/cavity. As innerdistal portion132 movestarget tissue130 towardcutting blade166 and/or outerdistal portion162moves cutting blade166 towardtarget tissue130, theextended cutting blade166 may cut through the target tissue.

In some examples, innerdistal portion132 may be capable of axial rotation. In such examples, a first sample of target tissue may be resected, and then innerdistal portion132 may rotate, for example, 180 degrees or less, to deposit the first tissue sample in an unused space oppositeside ports122. Innerdistal portion132 may then rotate, for example 180 degrees or less to resect a second tissue sample. In some examples, small dissection tools may oscillate back and forth across the cutting arc length instead of one dissection tool extending the entire cutting arc length.

FIG. 10 illustrates an alternative exemplarydistal portion142′ including innerdistal portion132′. In some examples,distal end134′ of innerdistal portion132′ may extend distally and radially outward so as to contact the distalmost ends of outerdistal portion162. In such examples, dissection tool164 (such as blade166) may not need to be retracted within outerdistal portion162. For example, a cutting blade may be positioned on the distalmost end of outerdistal portion162. Such a cutting blade need not be retractable asdistal end134′ of innerdistal portion132′ may provide protection to the patient from the cutting blade during insertion and positioning ofdistal portion142.

In some examples, target tissue may be secured to innerdistal portion132 in any way known in the art. For example, hooks may be disposed on the exterior of innerdistal portion132. In other examples, innerdistal portion132 may include at least one hole large enough to provide a grasper access to tissue and to pull the tissue into innerdistal portion132. These graspers may extend from a proximal end ofdelivery device102, through a working channel (e.g., working channel114), to the “larger” hole(s) in innerdistal portion132. Further, innerdistal portion132 may include an internal ramp to facilitate these graspers access to the target tissue.

The many features of the disclosure are apparent from the detailed specification, and thus, it is intended by the appended claims to cover all such features of the disclosure which fall within the true spirit and scope of the disclosure. Further, since numerous modifications and variations will readily occur to those skilled in the art, it is not desired to limit the disclosure to the exact construction and operation illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the disclosure.

Other aspects of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.

Claims (19)

What is claimed is:

1. A tissue removal device, comprising:

a distal portion, comprising:

an outer distal portion including an outer lumen and a tissue removal tool configured to sever tissue, wherein the tissue removal tool is positioned about a full circumference of the outer distal portion and external of the outer lumen, the tissue removal tool is movable relative to portions of the outer distal portion proximate to the tissue removal tool;

an inner distal portion positioned within the outer lumen of the outer distal portion and having a closed distal end, a lumen, and at least one side port, wherein the lumen is configured to receive a medical device, and the inner distal portion is movable relative to the outer distal portion and the medical device; and

a gap between an outer surface of the inner distal portion and an inner surface of the outer distal portion.

2. The tissue removal device ofclaim 1, wherein the at least one side port is configured to apply suction to tissue adjacent to the inner distal portion.

3. The tissue removal device ofclaim 1, further comprising the medical device, wherein the distal portion attaches to the medical device.

4. The tissue removal device ofclaim 3, wherein the medical device is in fluid communication with the lumen of the inner distal portion and the at least one side port.

5. The tissue removal device ofclaim 4, wherein the distal portion is removably attached to the medical device.

6. The tissue removal device ofclaim 1, wherein the at least one side port includes a plurality of ports disposed on between approximately 270 degrees and approximately 90 degrees of a circumference of the inner distal portion.

7. The tissue removal device ofclaim 1, wherein the tissue removal tool is disposed within a cavity formed along a distal edge of the outer distal portion.

8. The tissue removal device ofclaim 6, wherein the inner distal portion and the outer distal portion are positioned so that the tissue removal tool circumferentially aligns with the plurality of ports.

9. The tissue removal device ofclaim 1, wherein the radial width of the gap is between approximately 3 mm and approximately 8 mm.

10. The tissue removal device ofclaim 1, wherein the medical device is an endoscope, and the tissue removal tool is a retractable cutting blade.

11. A tissue removal device, comprising:

a delivery device having an inner lumen extending from a proximal end of the delivery device to a distal end of the delivery device, wherein the delivery device is an endoscope;

a distal portion attached to an outer surface of the delivery device, the distal portion defining a longitudinal axis and comprising:

an outer distal portion including a tissue removal tool configured to sever tissue, wherein the outer distal portion is axially movable relative to the delivery device, and the tissue removal tool is positioned along a distal edge of the outer distal portion; and

an inner distal portion with a closed distal end and at least one side port in fluid communication with the lumen of the delivery device, wherein the inner distal portion is axially movable relative to the delivery device and the outer distal portion, wherein the at least one side port is angled relative to the longitudinal axis and in a distal direction toward the closed distal end.

12. The tissue removal device ofclaim 11, wherein the tissue removal tool is one of a cautery wire or a cutting blade.

13. The tissue removal device ofclaim 12, wherein, when the inner distal portion is in a first position, a proximal-facing wall of the inner distal portion contacts a distalmost end of the outer distal portion.

14. A tissue removal device, comprising:

a distal portion, comprising:

an inner distal portion including at least one side port and an inner lumen configured to receive a medical device; and

an outer distal portion including (1) a lumen configured to receive the inner distal portion, and (2) a cavity adjacent to the lumen and housing a tissue removal tool, wherein the cavity and the tissue removal tool are positioned along a distal edge of the outer distal portion, and the inner lumen is external of the cavity;

wherein the tissue removal tool is configured to sever tissue in response to the inner distal portion moving proximally relative to the outer distal portion and the tissue removal tool moving distally outward from the cavity.

15. The tissue removal device ofclaim 14, wherein the tissue removal tool is movable relative to portions of the outer distal portion proximate to the tissue removal tool.

16. The tissue removal device ofclaim 14, further comprising:

a gap between an outer surface of the inner distal portion and an inner surface of the outer distal portion, wherein a radial width of the gap is greater at a first side of the inner distal portion having the at least one side port than at a second side of the inner distal portion opposite of the first side.

17. The tissue removal device ofclaim 14, wherein the tissue removal tool is movable from within the cavity in response to pushing the tissue removal tool of the outer distal portion.

18. The tissue removal device ofclaim 14, wherein the at least one side port of the inner distal portion is angled in a distal direction toward a distal end of the inner distal portion.

19. The tissue removal device ofclaim 14, wherein the tissue removal tool extends about a full circumference of the inner distal portion.

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